Continued Access Protocol

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Arctic Front Cardiac Cryoablation System

• Registration Number: NCT00889681
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.

Detailed Description

1. To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects free from one or more primary safety outcome measures-Cryoablation Procedure Events (CPEs) and Major Atrial Fibrillation Events (MAFEs), in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).

2. To evaluate the effectiveness of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects with success in the primary effectiveness outcome measure of Long Term Clinical Success (LTCS) in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).

3. To evaluate the acute performance of the modified Arctic Front® Cardiac CryoAblation Catheter System for comparison with the Arctic Front® Cardiac CryoAblation Catheter System used in the PS-023 STOP AF Pivotal Trial.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2014-02-03
• Results First Submitted QC: 2014-03-26
• Results First Posted: 2014-04-25
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Subjects must fulfill ALL of the following criteria:

1. Documented PAF:

   • diagnosis of paroxysmal atrial fibrillation (PAF) (Section 9.1.18, General Protocol Terminology), AND
   • 2 or more episodes of AF during the 3 months preceding the Consent Date, at least 1 of which must be documented with a tracing

2. 18 and 75 years of age

3. Failure for the treatment of AF (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of PAF: flecainide, propafenone, sotalol or dofetilide.

Exclusion Criteria

ANY of the following is regarded as a criterion for excluding a subject from the study:

1. Any previous left atrial (LA) ablation (except permissible retreatment subjects)

2. Any previous LA surgery

3. Current intracardiac thrombus (can be treated after thrombus is resolved)

4. Presence of any pulmonary vein stents

5. Presence of any pre-existing pulmonary vein stenosis

6. Pre-existing hemidiaphragmatic paralysis

7. Anteroposterior LA diameter > 5.5 cm by TTE

8. Presence of any cardiac valve prosthesis

9. Clinically significant mitral valve regurgitation or stenosis

10. Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date

11. Unstable angina

12. Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date

13. Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)

14. NYHA class III or IV congestive heart failure

15. Left ventricular ejection fraction (LVEF) < 40%

16. 2º (Type II) or 3º atrioventricular block

17. Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)

18. Brugada syndrome

19. Long QT syndrome

20. Arrhythmogenic right ventricular dysplasia

21. Sarcoidosis

22. Hypertrophic cardiomyopathy

23. Known cryoglobulinemia

24. Uncontrolled hyperthyroidism

25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.

26. Any woman known to be pregnant

27. Any woman without freedom from pregnancy as demonstrated by one or more of the following conditions:

    • negative β-HCG test within 7 days prior to Start Date
    • history of surgical sterilization
    • postmenopausal and free of menses for at least 12 months.

28. Life expectancy less than one (1) year

29. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study

30. Unwilling or unable to comply fully with study procedures and follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ablation	Arctic Front Cardiac Cryoablation System	All study subjects will be receive cryo ablation with the experimental devices and, optionally, an Atrial Fibrillation Drug.

Primary Outcome Measures

Name	Time	Method
Cryoablation Procedure Events (CPEs)	365 days	Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.
Freedom From Major Atrial Fibrillation Events (MAFE)	365 days	Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.
Long-term Clinical Success	180 days	Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.
Acute Procedural Success (APS)	At the conclusion of the cryoablation procedure	Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.

Trial Locations

Locations (10)

Bay Heart Group; 🇺🇸 Tampa, Florida, United States

Virginia Commonwealth University Health System; 🇺🇸 Richmond, Virginia, United States

Stanford Hospital & Clinical; 🇺🇸 Stanford, California, United States

Banner Good Samaritan; 🇺🇸 Phoenix, Arizona, United States

Inova Research Center; 🇺🇸 Falls Church, Virginia, United States

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Baylor Heart & Vascular Hospital; 🇺🇸 Dallas, Texas, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States